Training Courses (on-site and instructor-led virtual training may be requested)
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Date
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Course (click to view description and register) |
Duration
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Location
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| Jun 10
- Jun 13 |
Oracle's Argus Safety Basics |
4 days |
San Mateo, CA
On-Site
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This 4-day course covers the basic features of Argus Safety, Interchange, Dossier, Reconciliation, and End of Study Unblinding.
Functionality Covered:
- Overview of the System
- Common Functions
- Case Processing
- Coding Terms and MedDRA Browser
- Dashboards and Worksites
- Practical Case Management
- End of Study Unblinding
- Reconciliation
- Dossier
Who Should Attend:
This class is designed for people with no prior experience with Oracle's Argus Safety Suite. Prior Drug Safety experience is highly desirable.
Instructors:
Rodney Lemery
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Jun 17
- Jun 20 |
Oracle's Argus Safety Administration |
4 days |
San Mateo, CA
On-Site
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This 4-day course covers the administrative functions of Argus Safety and Interchange.
Functionality Covered:
- Product and License Configuration
- Regulatory Reporting Configuration
- Study Configuration
- Codelist Maintenance
- Workflow and User Maintenance
- Misc. Configuration (i.e. Dictionaries and auto-encoding
- field labels
- field validations)
- Letter and Narrative Configuration
- AG Service Maintenance
- Interchange Maintenance
Who Should Attend:
This class is designed for people with minimal application administration experience. Prior Oracle application experience is desirable.
Instructors:
Rodney Lemery
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Jul 08
- Jul 12 |
Oracle Clinical Basics |
5 days |
San Mateo, CA
On-Site
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This 5-day course covers all the subsystems in the clinical data management application.
Functionality Covered:
- Navigate through the Oracle Clinical application
- Model CRFs
- Define standard objects in the Global Library
- Design studies in Oracle Clinical
- Enter patient data in the database
- Write validation and derivation procedures
- Resolve discrepancies
- Set up labs and normal lab ranges
- Load data electronically
- Extract data to SAS
- Lock and freeze studies
Who Should Attend:
This class is designed for people with no prior experience with Oracle Clinical. Prior data management experience is highly desirable.
Instructors:
Steven Rifkin
Course Hours:
Mon-Thurs: 9 a.m. - 5 p.m. Fri: 9 a.m. - 2 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Jul 15 |
Oracle Clinical Complex Procedures |
1 day |
San Mateo, CA
On-Site
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This 1-day course is geared toward individuals who have some experience with Oracle Clinical. Course participants will learn how to write standard and advanced validation procedures in the clinical data management system.
Functionality Covered:
- Review of Creating Simple Procedures
- PL/SQL and Oracle Clinical Cursors
- Package Structure
- Retrieval Order for a Simple Procedure
- Retrieval in Complex Procedures
- Limiting Cursor Fetches
- Detecting Missing Data
- Custom Code
- Aggregation and Lags
- Using Thesaurus DVG Values
- Using Lab Range Values
- Test Mode
- Detail Variables
- External Functions
Who Should Attend:
This class is designed for people who will be writing validation procedures in the clinical data management system.
Instructors:
Steven Rifkin
Course Hours:
9 a.m. - 4 p.m.
Private On-site Course
$3,000.00 + cost of training materials
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| Jul 16 |
Oracle Clinical Data Model |
1 day |
San Mateo, CA
On-Site
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This 1-day class explains the Oracle Clinical data model, which is necessary for writing some advanced validation procedures, as well as writing enhancements and customizations for the system. Instructor will also cover some other advanced areas in Oracle Clinical, such as labs, and will answer student questions on any topic related to Oracle Clinical.
Functionality Covered:
- General Considerations
- Study Design Subsystem
- Global Library Subsystem
- Data Collection Definition Subsystem
- Data Capture
- Turning normalized data into de-normalized views
- Discrepancy Management
- Test Mode
- Journal Tables
Who Should Attend:
This class is designed for people who will be developing custom reports in Oracle Clinical, or creating interfaces between Oracle Clinical and other systems.
Instructors:
Steven Rifkin
Course Hours:
9 a.m. - 3 p.m.
Private On-site Course
$3,000.00 + cost of training materials
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| Jul 17 |
Oracle Clinical Administration |
1 day |
San Mateo, CA
On-Site
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This 1-day course covers the administrative functions of Oracle Clinical.
Functionality Covered:
- System Architecture
- Installation Review
- Parameterized Submission Facility (PSUB)
- Adding New Users
- Administering Reference Codelists
- Administering Discrepancy Management
- Menu Structure and Module Maintenance
- Replication Overview
- Oracle Clinical APIs
Who Should Attend:
This class is designed for people who will be performing Oracle Clinical application administration functions.
Instructors:
Steven Rifkin
Course Hours:
9 a.m. - 4 p.m.
Private On-site Course
$3,000.00 + cost of training materials
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| Jul 18
- Jul 19 |
Oracle Clinical Advanced Topics |
2 days |
San Mateo, CA
On-Site
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This 2-day course covers Oracle Clinical’s advanced features. Participants will also learn how to customize the clinical data management system, in order to meet specific organizational requirements.
Functionality Covered:
- Set up a Study Schedule
- Track Missing and Overdue DCMS
- Effectively use Qualifying Values
- Create Graphic Layouts
- Configure the Discrepancy Management System
- Use the Mass Change Functionality
- Create Custom Data Extract Views
- and more ...
Who Should Attend:
This class is designed for people who have had a least one year of experience with Oracle Clinical.
Instructors:
Steven Rifkin
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
CDISC SDTM Implementation |
1 day |
San Mateo, CA
New Providence, NJ
On-Site
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This 1-day class covers lessons learned from the real world implementation of CDISC SDTM.
Functionality Covered:
- Project Definition
- Project Plan & Management
- Data Standard Analysis & Review
- Data Transformation Specification
- Data Transformation Definition
- Data Transformation to Standards
- Review and Validation of Transformations & Standards
- Domain Documentation for DEFINE.PDF and DEFINE.XML
- Case Report Form Annotation with CDISC Variables
Who Should Attend:
This class is designed for people working with CDISC SDTM model.
Instructors:
Sy Truong
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$3,000.00 + cost of training materials
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| Inquire |
Empirica Topics |
2 days |
On-Site
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This 2-day course covers the basic use and administration of Empirica Topics and consists of presentations, demonstrations, and hands-on exercises. Each student will be connected to the live Empirica Topics training database.
Functionality Covered:
- Adding Topics
- Reporting on Topics
- Configuring Fields
- Configuring States
- Configuring Action States
- Configuring E-mail Notification Rules
Who Should Attend:
The course is appropriate for Empirica Topics users, administrators, and members of the project team involved in configuring the solution.
Instructors:
Rodney Lemery
Course Hours:
9 a.m. - 5 p.m.
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| Inquire |
MedDRA Coding |
2 days |
On-Site
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This 2-day course covers the use of the MedDRA dictionary in coding clinical trial and post-marketing data.
Functionality Covered:
- Overview of the MedDRA dictionary (structure and format)
- General coding principals based on the current MedDRA Points to Consider
- Practical exercises in MedDRA coding
- General analysis and reporting principals based on the current MedDRA Data Retrieval and Presentation: Points to Consider
- Practical exercises in MedDRA analysis and reporting
Who Should Attend:
The first day of the class is designed for clinical coders using the MedDRA dictionary to code verbatim terms originating from clinical and post-marketed data. While the MSSO’s MedDRA brower is used to facilitate the class, the content is coding tool independent. The second day of the class is designed for the analysis and reporting team that uses the MedDRA coded data to group, analyze, and display hierarchical coded data from the WHO Drug dictionary.
Instructors:
Rodney Lemery
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,500.00 + cost of training materials
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| Inquire |
Oracle Clinical for Programmers |
3 days |
San Mateo, CA
New Providence, NJ
On-Site
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This 3-day course provides an overview of Oracle Clinical, its functionality, and aspects of the underlying database structure will be discussed.
Functionality Covered:
- Overview of the Drug Development Process
- Modeling Case Report Forms
- Use of the Global Library
- Creating DCIs and DCMs
- Data Entry
- Study Definition
- Discrepancy Management
- Data Clarification Forms
- Validation Procedures
- Data Extracts
Who Should Attend:
This class is designed for Programmers who will be interacting with Data Managers for producing reports and performing Oracle Clinical system customization work.
Instructors:
Steven Rifkin
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
Oracle's Adverse Event Reporting System (AERS) Administration |
2 days |
San Mateo, CA
New Providence, NJ
On-Site
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This 2-day course covers the administrative functions of Oracle's AERS.
Functionality Covered:
- System Overview
- Workflow
- Configuration
- Security
- User Administration
- Report Administration
- Application Administration
- AERS Architecture
- TMS Configuration
- Data Model Overview
- Oracle Portal Basics
- Oracle Discoverer Basics
Who Should Attend:
This class is designed for people with minimal application administration experience. Prior Oracle application experience is desirable.
Instructors:
Rodney Lemery
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
Oracle's Adverse Event Reporting System (AERS) Basics |
3 days |
San Mateo, CA
New Providence, NJ
On-Site
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This 3-day course covers the basic features of Oracle's AERS.
Functionality Covered:
- System Overview
- Workflow
- Case Entry
- Case Browse
- List Management
- Basic and Advanced Queries
- Reports
- Regulatory Submissions
- Validation
- Data Management
- Reconciliation
- Object Management
Who Should Attend:
This class is designed for people with no prior experience with Oracle's AERS. Prior Drug Safety experience is highly desirable.
Instructors:
Rodney Lemery
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
Oracle's Remote Data Capture (RDC) Administration |
2 days |
San Mateo, CA
New Providence, NJ
On-Site
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The objective of this 2-day course is to provide RDC users with an overview of the new features in the most recent version of RDC, which deal with study setup and administrative functions.
Functionality Covered:
- Overview
- DCI Layouts
- System Configuration
- Study Configuration
- Ongoing RDC Administration
Who Should Attend:
This class is designed for Oracle Clinical administrators who understand what can be configured to RDC Onsite, as well as sponsor personnel who setup and configure databases for clinical trials in which RDC Onsite will be used.
Instructors:
Steven Rifkin
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
Oracle's Remote Data Capture (RDC) for Site Personnel |
1/2 day |
San Mateo, CA
New Providence, NJ
On-Site
Virtual
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This custom 4-hour course provides Oracle's RDC site users with an understanding of how to use RDC at sites. Training is tailored to the study that the users will run using RDC.
Functionality Covered:
- Overview
- Data Entry Using RDC
- Discrepancy Management Using RDC
- Document Verification and Approval
- Special RDC Features
- Role based functionality
Who Should Attend:
This class is designed for site personnel who will be conducting studies which use Oracle's Remote Data Capture option.
Instructors:
Steven Rifkin
Lori Venable
Tammy Dutkin
Course Hours:
Scheduled upon site's availability.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
Oracle's Remote Data Capture (RDC) for Sponsor Personnel |
1 day |
San Mateo, CA
New Providence, NJ
On-Site
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The objective of this 1-day course is to provide RDC sponsor personnel with an understanding of how to work with RDC, so various configuration options can be evaluated.
Functionality Covered:
- Overview
- Concepts
- Data Entry Using RDC
- Discrepancy Management Using RDC
- Document Verification and Approval
- Reports
Who Should Attend:
This class is designed for sponsor personnel who will be deciding how to configure and conduct studies using Oracle's Remote Data Capture solution. It also could be appropriate for those who will provide training to site personnel that will participate in RDC studies. Knowledge of Oracle Clinical is not required.
Instructors:
Steven Rifkin
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$3,000.00 + cost of training materials
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| Inquire |
Oracle's Remote Data Capture (RDC) Upgrade to 4.6 |
1 day |
San Mateo, CA
New Providence, NJ
On-Site
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The objective of this 1-day course is to provide RDC users with an overview of the new features in the newest version of RDC.
Functionality Covered:
- Overview
- Blinding DCI
- Conditional Branching
- Flex Studies
- Other Topics
Who Should Attend:
This class is designed for sponsor personnel who will be configuring and conducting studies using Oracle's Remote Data Capture solution.
Instructors:
Steven Rifkin
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$3,000.00 + cost of training materials
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| Inquire |
Oracle's Thesaurus Management System (TMS) Advanced |
2 days |
San Mateo, CA
New Providence, NJ
On-Site
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This 2-day course will examine the more advanced functions of TMS, such as versioning and reporting.
Functionality Covered:
- Dictionary Definition
- Drill-Down Configuration
- Introduction to PL/SQL
- TMS Data Model
- Versioning Script Programming
- Search Algorithm Programming
Who Should Attend:
This class is designed for people who will be performing TMS application administration functions.
Instructors:
Rodney Lemery
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
Oracle's Thesaurus Management System (TMS) Basics |
3 days |
San Mateo, CA
New Providence, NJ
On-Site
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This 3-day course covers the functions of TMS, including the steps for loading and updating dictionaries.
Functionality Covered:
- Overview
- Common Functions
- Dictionary Definition
- Repository Maintenance
- Oracle Clinical Integration
- Repository Browsing
- Verbatim Term Assignments
- MedDRA Basics
- WHODrug Basics
- Practical Dictionary Coding
Who Should Attend:
This class is designed for people who will be maintaining dictionaries using TMS, and coding AE and medications.
Instructors:
Rodney Lemery
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
PL/SQL for Oracle Clinical Users |
1 day |
San Mateo, CA
New Providence, NJ
On-Site
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This 1-day class introduces features of PL/SQL which would be useful to an Oracle Clinical user who desires to create specialized functions and procedures to read and/or update the underlying Oracle Clinical database tables. These specialized programs might be useful for completing projects like with interfacing with other systems and creating specialized reports.
Functionality Covered:
- What is PL/SQL
- Language Fundamentals
- Language Elements
- Functions and Procedures
- Packages
- Exception Handling
- File I/O with UTIL_FILE Package
Who Should Attend:
This class is designed for people who will be writing validation procedures or creating specialized functions in the clinical data management system.
Instructors:
Steven Rifkin
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$3,000.00 + cost of training materials
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| Inquire |
Siebel Administration |
3 days |
San Mateo, CA
New Providence, NJ
On-Site
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This 3-day course covers the administrative functions that are shared across all of the Siebel applications used within the life sciences industry.
Functionality Covered:
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- Server component administration and maintenance
- Workflow administration
- User account administration including responsibilities and positions
- List of Value (LOV) administration
- Currency conversions
- Audit trail management
- State Model management
- iHelp administration
- Communication and messaging
Who Should Attend:
This class is designed for Siebel application administrators with minimal Siebel experience.
Instructors:
Param Singh
Karen Ouyang
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
Siebel iHelp Development and Administration |
1/2 day |
San Mateo, CA
On-Site
Virtual
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This 4-hour course covers the development and administration of Siebel iHelp.
Functionality Covered:
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- Creating new iHelp items
- Modifying existing iHelp items
- Creating internal hyperlinks within iHelp items to screens/views
- Creating external hyperlinks within iHelp items
- Field and button highlights
- Associating iHelp items to Responsibilities
- Associating iHelp items to screens
- Lifecycle management
- Version control
Who Should Attend:
This class is designed for Siebel users who would like to create and manage iHelp articles.
Instructors:
Richard Gavan
Course Hours:
1 p.m. - 5 p.m.
Private On-site Course
$2,000.00 + cost of training materials
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| Inquire |
WHO Drug Coding |
2 days |
On-Site
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This 2-day course covers the use of WHO Drug Dictionary in coding clinical trial and post-marketing data.
Functionality Covered:
- Overview of the WHO Drug Dictionary (Structure and Format)
- General Coding Principals
- Quality of Source Data
- Use of Auto-encoders
- Use of Abbreviations
- Contextual Coding
- Coding Single Ingredients Products
- Coding Multi-Ingredient Products
- Coding Vague Terms
- Coding Extemporaneous (aka galenic) formulations
- Coding Old Formulations
- Coding Chemo and Radiotherapy
- Coding Herbal/Eastern Medicines
- Coding Investigational Products
- Coding Vaccines
- Coding Multivitamins
- Handling Reported Non-Therapies
- Application and Use of ATC Codes
- Practical Exercises in WHO Drug Coding
Who Should Attend:
The first day of the class is designed for clinical coders using the WHO Drug dictionary to code verbatim terms originating from clinical and post marketed data. While the TMS HTML Browser is used to facilitate the class, the content is coding tool independent. The second day of the class is designed for analysis and reporting staff that use the WHO Drug coded data to group, analyze and display hierarchical coded data from the WHO Drug dictionary.
Instructors:
Rodney Lemery
Course Hours:
9 a.m. - 5 p.m.
Private On-site Course
$2,500.00 + cost of training materials
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